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1 Introduction and Themes of the Workshop
1 Introduction and Themes of the Workshop
Pages 1-8
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Clinics that offer stem cell therapies for a wide range of diseases and conditions have been established throughout the world, both in newly industrialized countries such as China, India, and Mexico and in developed countries such as the United States and various European nations (Lau et al., 2008)
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held a workshop in Washington, DC, on November 18, 2013, titled Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Unregulated Clinical Offerings. The workshop brought together researchers, clinicians, patients, policy makers, and others from North America, Europe, and Asia to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from treatments that are dangerous or ineffective or by steering
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Some are available as procedures offered by clinics, while others, such as skin care products, are available for direct purchase through online marketplaces. These treatments are described as using stem cells from other humans, from animals, or from plants; feature the use of autologous stem cells, in which cells are extracted from an individual, manipulated in a laboratory, and reinfused or reimplanted into that same person; or advertise the use of tissue-specific stem cells.
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From page 4... ...
While the majority of clinical trials involving stem cells are thought to take place in the United States, there are a large number being conducted elsewhere, particularly in Europe and East Asia; when examining clinical trials involving only mesenchymal stem cells (Dominici et al., 2006) , East Asia is thought to be conducting the majority of studies (see Table 1-1)
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Yet people also need to be informed that stem cell therapies have great potential, that clinical trials are under way, and that regenerative medicine bears tremendous promise for the future. TABLE 1-1 Number of Clinical Trials Under Way Using Stem Cells Clinical Trials Clinical Trials Using Country/Region Using Stem Cells Mesenchymal Stem Cells United States 2,532 73 Europe 993 98 East Asia (including China)
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From page 6... ...
While governments have an obligation to protect patients from ineffective therapies and fraudulent advertising, public policies could also reflect the needs of patients and their autonomy in making medical decisions. Generating needed information: Governments, professional associations, patient groups, and other organizations all can help generate the information needed to develop effective regulations and allow patients to make informed choices.
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From page 7... ...
Finally, Chapter 6 discusses important challenges, evidence gaps, and possible paths forward to make safe and effective stem cell treatments available as quickly as possible.
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